Job in Germany : Quality Manager (m / w / d) Early Clinical Trials

Akkodis Germany Tech Experts GmbH; Cárcer; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Ein etabliertes Unternehmen sucht einen Qualitätsmanager für frühe klinische Studien. In dieser Rolle sind Sie verantwortlich für die Organisation von Audits, die Erstellung von Aktionsplänen und die Unterstützung bei der Qualitätssicherung. Sie bringen umfangreiche Erfahrung im Qualitätsmanagement und ein tiefes Verständnis der regulatorischen Anforderungen mit. Dies ist eine hervorragende Gelegenheit, in einem dynamischen Umfeld zu arbeiten, das Ihnen vielfältige Weiterbildungsmöglichkeiten und eine ausgewogene Work-Life-Balance bietet. Wenn Sie ein Teamplayer sind und eine Leidenschaft für Qualität haben, freuen wir uns auf Ihre Bewerbung.

Servicios

Work-Life-Balance

Attraktive Vergütung

Vielfältige Weiterbildungsmöglichkeiten

Teamevents

Globales Netzwerk

Mitarbeiterempfehlungsprogramm

Formación

• Mehrjährige relevante Erfahrung im Qualitätsmanagement und in klinischen Studien.
• Fließende Sprachkenntnisse in Deutsch und Englisch sind erforderlich.

Responsabilidades

• Organisation und Unterstützung bei der Durchführung von Audits und Inspektionen.
• Erstellung und Verwaltung kontrollierter Dokumente und Vorlagen.

Conocimientos

Qualitätsmanagement

Klinische Forschung

Regulatorische Anforderungen

Teamarbeit

Prozessverbesserung

Fließend in Deutsch

Fließend in Englisch

Educación

Abschluss in Naturwissenschaften

Master in Klinischen Studienmanagement

Descripción del empleo

Quality Manager (m / f / d) Early Clinical Trials

Working hours: full-time

Akkodis - formed through the merger of AKKA & Modis - is a global leader in engineering & IT. As a global partner in an ever-changing technology & competitive environment, we support our customers with our 360° offering to create a more sustainable & smarter future. United by our shared passion for technology & talent, we look at the world from a new perspective. Our 50,000 motivated engineers & digital experts go beyond the possible every day to create the incredible.

At Akkodis Life Sciences, we staff projects throughout Germany for renowned clients in the pharmaceutical, biotech and chemical industries. We are looking for a Quality Manager (m / f / d) Early Clinical Trials for a very well-known pharmaceutical company.

Details:

• Start: ASAP
• Location: Greater Ulm area
• Utilization: 100%
• Duration: Until 30.09.2026

Responsibilities:

• Organization / support in the preparation, implementation and follow-up of inspections, internal and external audits and assessments.
• Timely creation of action plans and their follow-up in close cooperation with Quality Medicine Germany.
• Support and responsibility for the creation and management of controlled documents and templates for processes as well as checking for relevance to functions and comparison with SOP distribution lists and familiarization lists.
• Independent implementation of quality controls, e.g. check of relevant audit procedures and documentation (source data, CRFs, ICs, internal process descriptions, etc.).
• Initiation of process improvement measures and CAPAs.
• Support the team by providing advice and assistance on issues related to quality, processes, SOPs, improvement activities and data protection.

Your Profile:

• Degree with several years of relevant experience, e.g. a degree in natural sciences (e.g. biology, pharmacy, chemistry), pharmaceutical sciences / clinical research, health sciences / public health, quality management / regulatory affairs. Or a Master's degree in Clinical Trial Management, GCP or Quality Management in Healthcare.
• Or equivalent qualification with relevant education / further training and many years of professional experience.
• Many years of experience in the field of phase 1 clinical trials (e.g. as a Study Nurse, Clinical Research Associate, GCP Auditor).
• Very good understanding of clinical research, quality management and regulatory requirements.
• Very good knowledge of the relevant international and national regulations, e.g. GCP, AMG, MPG, GCP-V, relevant guidelines (ICH, FDA, EMA).
• Experience in quality management and training of employees.
• Fluent in written and spoken German and English.
• Team spirit and diversity.

Benefits:

• Work-life balance.
• Attractive remuneration.
• Versatile further training opportunities.
• Team and sporting events.
• Global network.
• Attractive employee referral program.

Benefits may vary depending on position and location. An overview of our benefits can be found on our website under Careers and Benefits.

Then we should definitely get to know each other! Please send us your CV preferably via our online application platform or via the e-mail address below and we will get in touch with you.

About Us:

We combine our many years of experience as a personnel service provider with extensive expertise in IT professions. You will find a wide range of different jobs in this field in our job advertisements. Our recruiters know exactly how the industry is developing and will find the job that suits you best.